The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Investigational Mask, Conventional mask.
- Who it may be relevant to
- Registry conditions: COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. However, poor performance of the NIV mask and poor comfort can make NIV therapy harder to tolerate. This study will assess if a new mask helps to improve the breathing of people on NIV and normalize blood gases.
Detailed description
Participants are moved to the sleep laboratory for the night where they are provided with beds.
* The participants are put on their prescribed airway pressure support with the first randomized mask. * After at least 60 minutes of recording, participants are awakened to switch back to the second mask. They are then allowed to sleep uninterrupted for the rest of the night.
Interventions
- Device Investigational Mask
Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep. - Device Conventional mask
Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep.
Primary outcome measures
- Change in respiratory rate [Time frame: 4 hours]
Eligibility criteria
Inclusion criteria
- Age over 18 years
- Prescribed nocturnal NIV for COPD or OHS
- Able to complete an overnight sleep study
- Comfortable to sleep on a standard double bed
- Capacity to complete informed consent
Exclusion criteria
- Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data)
- Prescribed IPAP above 25 cmH2O
- Allergic to adhesive of the sensors
- Self-reported cold/flu symptoms
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
New Zealand · 1 center
- Fisher and Paykel Healthcare Sleep Laboratory — Auckland
Identifiers
NCT: NCT06972589 · U1111-1322-0270 · CIA-356